Reentry device

ABSTRACT

The disclosure provides apparatus and methods for reentering a true lumen. The reentry catheter includes a shaft that includes a proximal opening in a proximal end of the shaft, a J-shaped filler in a distal end of the shaft, and a distal side opening in a sidewall of the shaft. The distal side opening is adjacent to the J-shaped filler. A passageway extends between the proximal opening and the distal side opening. The proximal opening, the distal side opening, and the passageway each are configured for the passage of an elongate medical device there through. A movable cover is hingedly attached to the sidewall of the shaft biased in a closed position and configured to occlude the distal side opening when in the closed position. The elongate medical device is configured to open the movable cover, the movable cover is configured to facilitate reentry to a true lumen.

BACKGROUND

The present disclosure relates generally to apparatus and methods forcatheters, and more specifically, for a reentry catheter device.

Chronic total occlusions (CTOs) are a common finding in patients withcoronary artery disease. Treatment of coronary CTOs remains achallenging obstacle, posing a considerable barrier to achievingsuccessful complete revascularization. The choice of revascularizationincludes endovascular treatment, which is a very complicated andexpensive surgery.

Endovascular treatment of CTOs is increasing while the recanalizationthrough CTO remains challenging. The most common method for crossingocclusions uses hydrophilic wires and catheters in the subintimal planefor a portion of the occlusion. One of the primary limitations tosuccessful treatment of CTOs is reported to be the failure to re-enterthe true lumen after subintimal crossing of the occlusion.

An additional limitation in some cases is that the true lumen reentry isnot achieved until subintimal passage to a site significantly remotefrom the level of vessel lumen patency, which causes subintimalangioplasty or stenting to extend beyond the occluded segment. Further,a reentry device may cause unnecessary trauma during the reentryprocedure. Therefore, it would be desirable to provide an inexpensiveapparatus and a relatively simple method for re-entering the true lumenat the desired region close to the occlusion without unnecessary trauma.

SUMMARY

The present disclosure provides apparatus and methods for removingthrombus outside of a reentry catheter by providing a third lumen withan operable member in the reentry catheter.

One embodiment of the reentry catheter comprises a shaft that includes aproximal opening in a proximal end of the shaft, a J-shaped filler in adistal end of the shaft, and a distal side opening in a sidewall of theshaft. The distal side opening is adjacent to the J-shaped filler. Apassageway extends between the proximal opening and the distal sideopening. The proximal opening, the distal side opening, and thepassageway each are configured for the passage of an elongate medicaldevice there through. A movable cover is hingedly attached to thesidewall of the shaft. The movable cover is biased in a closed positionand configured to occlude the distal side opening when in the closedposition. The elongate medical device is configured to open the movablecover, and the movable cover is configured to facilitate reentry to atrue lumen.

A method to use the above embodiment of the reentry catheter during anendovascular treatment includes: inserting a wire guide by puncturingthrough a vessel wall of the true lumen. An operator advances a firstcatheter having a distal opening along a wire guide until the distalopening is distal to the occlusion. The operator then removes the wireguide from the first catheter and advances a reentry catheter inside thefirst catheter. The reentry catheter includes a proximal end of theshaft, a J-shaped filler in a distal end of the shaft, a distal sideopening in a sidewall of the shaft, the distal side opening adjacent tothe J-shaped filler, and a passageway extending between the proximalopening and the distal side opening, the proximal opening, the distalside opening, and the passageway each being configured for the passageof an elongate medical device there through, a movable cover hingedlyattached to the sidewall of the shaft, which is biased in a closedposition and configured to occlude the distal side opening when in theclosed position. The operator advances the reentry catheter until thedistal side opening is distal to the distal opening of the firstcatheter. The reentry catheter reenters the true lumen by opening themovable cover with the elongate medical device.

BRIEF DESCRIPTION OF THE DRAWINGS

The disclosure can be better understood with reference to the followingdrawings and description. The components in the figures are notnecessarily to scale, emphasis instead being placed upon illustratingthe principles of the disclosure. Moreover, in the figures, likereferenced numerals designate corresponding parts throughout thedifferent views.

FIG. 1 is an illustration of a first embodiment of a reentry catheterwith a movable cover in a closed position.

FIG. 2 is an illustration of the first embodiment of a reentry catheterwith an elongate medical device.

FIG. 3 is an illustration of the first embodiment of a reentry catheterwith a movable cover in an open position.

FIG. 4 is an illustration of an enlarged cross section view of anembodiment of the movable cover of a reentry catheter.

FIG. 5 illustrates a vessel having an occlusion.

FIG. 6 illustrates a first step in the method of using a reentrycatheter.

FIG. 7 illustrates a second step in the method of using a reentrycatheter.

FIG. 8 illustrates a third step in the method of using a reentrycatheter.

FIG. 9 illustrates a fourth step in the method of using a reentrycatheter.

FIG. 10 illustrates an enlarged view of the fourth step in the method ofFIG. 9.

FIG. 11 illustrates an enlarged view of a fifth step in the method ofusing a reentry catheter.

FIG. 12 illustrates an enlarged view of a sixth step in the method ofusing a reentry catheter.

FIG. 13 illustrates an enlarged view of a seventh step in the method ofusing a reentry catheter.

FIG. 14 illustrates an enlarged view of an eighth step in the method ofusing a reentry catheter.

FIG. 15 illustrates an enlarged view of a ninth step in the method ofusing a reentry catheter.

FIG. 16 illustrates a tenth step in the method of using a reentrycatheter.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

In the present application, the term “proximal” refers to a directionthat is generally toward a physician during a medical procedure, whilethe term “distal” refers to a direction that is generally toward atarget site within a patient's anatomy during a medical procedure. Thefigures shown are for illustration purpose only and not to scale. Theactual catheters comply with the standard manufacture and catheterdesign procedures.

Referring now to FIGS. 1-3, a first embodiment of a reentry catheter 100for an endovascular treatment is described. The reentry catheter 100includes an elongate shaft 110 having a proximal opening 111 in aproximal end 112 of the elongate shaft 110, a J-shaped filler 116 in adistal end 114 of the elongate shaft 110, a distal side opening 118 in asidewall 140 of the elongate shaft 110. The distal side opening 118 isadjacent to the J-shaped filler 116. A passageway 120 extends betweenthe proximal opening 111 and the distal side opening 118. The proximalopening 111, the distal side opening 118, and the passageway 120 areeach configured for the passage of an elongate medical device 150 therethrough.

The elongate medical device 150 may be a wire guide or other medicaldevice that is configured to pass through a catheter. The elongatemedical device 150 may include a manipulating device 160 at the proximalend thereof. A movable cover 130 is hingedly attached to the sidewall140 of the shaft 110. The movable cover 130 is biased in a closedposition and configured to occlude the distal side opening when in theclosed position as shown in FIG. 2. The biased closed movable cover 130provides a safer reentry procedure with less risk of trauma to thevessel. The elongate medical device 150, such as a wire guide, isconfigured to open the movable cover 130.

FIG. 3 illustrates the first embodiment of a reentry catheter 100 with amovable cover 130 in an open position. In FIG. 3, a distal end of theelongate medical device 150 pops open the movable cover 130 and a distalend of the elongate medical device 150 exits through the distal sideopening 118. An operator may gain reentry to a true lumen by advancingthe elongate medical device 150 further so that the distal end of theelongate medical device 150 punctures the vessel wall. Alternatively oradditionally, the opened movable cover 130 may be configured tofacilitate reentry to a true lumen by supporting and guiding the distalend of the elongate medical device 150. For example, when the movablecover is in an open position, the biasing of the movable cover 130 andthe J-shaped filler 116 confines the movement of the elongate device 150and thus guides its reentry direction to the desired position within arelatively narrow angle. To help the operator identify the precisereentry location, the distal side opening 118 is marked by surroundingradiopaque material in the sidewall 140. Similarly, the J-shaped filler116 includes radiopaque material to help the operator locate the reentrycatheter in the vessel way. Additionally, the elongate medical device150 includes radiopaque material at a distal end thereof. For example,the elongate medical device may include a radiopaque catheter balloon atthe distal end.

A nitinol material may be used because of its soft property to createthe proximal end 112 of the reentry catheter 100. Thus, the reentrycatheter may easily be manipulated in the anatomy to accommodate theangles, curves, and turns. The diameter of the reentry catheter 100 isin the range of about 0.035 mm to about 0.038 mm to accommodate theelongate medical device 150 having a diameter of about 0.014 mm.

FIG. 4 illustrates an enlarged cross section view of an embodiment ofthe movable cover 130 of a reentry catheter. The movable cover 130includes one of the following mechanisms: a spring, a magnet, a stopper,or a hinge pin. The movable cover 130 may also include shape memorymaterial. The movable cover 130 includes a plurality of radiopaquemarkers: 132, 134, and 136. The radiopaque markers: 132, 134, and 136may have a rectangular shape or other reasonable shapes to help theoperator locate the position of the movable cover 130 accurately. Themovable cover 130 may have a different shape so that it may gain accessto a true lumen.

Alternatively or additionally, the movable cover 130 may include areentry needle 138 at the distal end thereof. When the movable cover 130includes the reentry needle 138, the side wall 140 also includes asheathe that accommodates the needle 138. Alternatively or additionally,the movable cover 130 may, the movable cover 130 may include arelatively sharp edge 139 configured to partially penetrate the vesselwall. In one embodiment, by including the radiopaque markers and one ofthe relatively sharp edge and the reentry needle in the movable cover,the reentry catheter provides an accurate reentry method describedbelow. The operator can use standard wire guide catheters to performreentry procedures with the reentry catheter.

FIG. 5 illustrates a vessel having an occlusion. The vessel includes avessel way 210 and an occlusion 200 that blocks most of the blood flowin the vessel. A desired reentry location to the true lumen 212 is at apoint near the distal end of the occlusion 200.

FIG. 6 illustrates a first step in the method of using a reentrycatheter. In this step, an operator inserts a wire guide 220 bypuncturing through a vessel wall 210 of the true lumen 212. The wireguide 220 punctures the vessel wall 210 at a location proximal to theocclusion 200. To achieve a successful true lumen reentry, the reentryregion should be distal and adjacent to the occlusion 200.

FIG. 7 illustrates a second step in the method of using a reentrycatheter. In this step, the operator advances a first catheter 230having a distal opening 232 along a wire guide until the distal opening232 is distal to the occlusion 200. The distal opening may be markedwith radiopaque material or other imaging agent to identify the positionof the distal opening.

FIG. 8 illustrates a third step in the method of using a reentrycatheter. In this step, the wire guide 220 is removed from the firstcatheter 230.

FIG. 9 illustrates a fourth step in the method of using a reentrycatheter. In this step, the operator advances an aforementioned reentrycatheter 100 inside the first catheter 230. The reentry catheter 100includes the elongate shaft having a proximal opening in a proximal endof the elongate shaft, a J-shaped filler in a distal end of the elongateshaft, a distal side opening in a sidewall of the elongate shaft.

FIG. 10 illustrates an enlarged view of the fourth step in the method ofFIG. 9. In the zoomed in view, the reentry catheter 100 includes anelongate medical device 150 that is configured to pass through thereentry catheter 100.

FIG. 11 illustrates an enlarged view of a fifth step in the method ofusing a reentry catheter. In this step, the operator advances thereentry catheter 100 until the movable cover 130 is distal to the distalopening 232 of the first catheter 230. The operator may use imagingdevice to image the distal opening 232, the J-shape filler 116, and themovable cover 130. A distance between the J-shaped filler 116 and thedistal opening 232 may be used to identify whether the reentry catheter100 is in the desired position distal to the distal opening 232. Apreferred distance between the J-shaped filler 116 and the distalopening 232 is about 3 mm to about 5 mm.

FIG. 12 illustrates an enlarged view of a sixth step in the method ofusing a reentry catheter. In this step, the operator feeds the elongatemedical device 150 until it pops open the movable cover 130. Themoveable cover 130 may be used to puncture back into the true lumen 212.

FIG. 13 illustrates an enlarged view of a seventh step in the method ofusing a reentry catheter. In this step, the elongate medical device 150reenters the true lumen 212 by opening the movable cover 130 andpuncturing into the true lumen 212.

FIG. 14 illustrates an enlarged view of an eighth step in the method ofusing a reentry catheter. In this step, the operator started to withdrawthe reentry catheter 100 back to the first catheter 230. Because themovable cover 130 is biased to a closed position, the reentry catheter100 does not cause unnecessary trauma to the vessel wall when movinginside the vessel wall 210.

FIG. 15 illustrates an enlarged view of a ninth step in the method ofusing a reentry catheter. In this step, the reentry catheter 100 isremoved from the first catheter 230.

FIG. 16 illustrates a tenth step in the method of using a reentrycatheter. In this step, the operator feeds the first catheter 230 overthe elongate medical device 150 into the true lumen 212. The firstcatheter 230 may be a balloon catheter or other catheters used inendovascular treatments.

The disclosed reentry catheter has a movable cover that is biasedclosed. This prevents bodily matter from entering the reentry catheterafter re-entry is achieved. The biasing of the movable cover may becontrolled by a spring, magnet, stopper, hinge pins, or shape memorymaterial mechanism. The reentry catheter does not require a needle topuncture through the true lumen which may cause trauma to the vessel.The reentry catheter may instead use the force of the moveable cover tofacilitate reentry to eliminate any accidental puncture. Eliminating theneedle allow physicians to select almost any type of wire guide theydesire to complete the reentry procedure.

While various embodiments of the reentry catheter have been described,it will be apparent to those of ordinary skill in the art that many moreembodiments and implementations are possible within the scope of theinvention. The different aspects of the described embodiments may becombined together to improve the performance of the reentry catheter.Accordingly, the invention is not to be restricted except in light ofthe attached claims and their equivalents. Moreover, the advantagesdescribed herein are not necessarily the only advantages of theinvention and it is not necessarily expected that every embodiment ofthe invention will achieve all of the advantaged described.

What is claimed is:
 1. A reentry catheter, comprising: a shaftcomprising a proximal opening in a proximal end of the shaft, a J-shapedfiller in a distal end of the shaft, a distal side opening in a sidewallof the shaft, the distal side opening adjacent to the J-shaped filler,and a passageway extending between the proximal opening and the distalside opening, the proximal opening, the distal side opening, and thepassageway each being configured for the passage of an elongate medicaldevice there through, a movable cover hingedly attached to the sidewallof the shaft, the movable cover biased in a closed position andconfigured to occlude the distal side opening when in the closedposition, wherein the elongate medical device is configured to open themovable cover, the opened movable cover being configured to facilitatereentry to a true lumen.
 2. The reentry catheter of claim 1, wherein thedistal side opening is marked by surrounding radiopaque material in thesidewall.
 3. The reentry catheter of claim 1, wherein the movable covercomprises one of the following mechanisms: a spring, a magnet, astopper, or a hinge pin.
 4. The reentry catheter of claim 1, wherein themovable cover comprises shape memory material.
 5. The reentry catheterof claim 1, wherein the movable cover comprises radiopaque material. 6.The reentry catheter of claim 1, wherein the J-shaped filler comprisesradiopaque material.
 7. The reentry catheter of claim 1, wherein theelongate medical device comprises radiopaque material at a distal endthereof.
 8. The reentry catheter of claim 1, wherein the elongatemedical device comprises a radiopaque catheter balloon.
 9. A method forremoving an occlusion in a true lumen, the method comprising: insertinga wire guide by puncturing through a vessel wall of the true lumen;advancing a first catheter having a distal opening along a wire guideuntil the distal opening is distal to the occlusion; removing the wireguide from the first catheter; advancing a reentry catheter inside thefirst catheter, the reentry catheter having a shaft comprising aproximal opening in a proximal end of the shaft, a J-shaped filler in adistal end of the shaft, a distal side opening in a sidewall of theshaft, the distal side opening adjacent to the J-shaped filler, and apassageway extending between the proximal opening and the distal sideopening, the proximal opening, the distal side opening, and thepassageway each being configured for the passage of an elongate medicaldevice there through, a movable cover hingedly attached to the sidewallof the shaft, the movable cover biased in a closed position andconfigured to occlude the distal side opening when in the closedposition; advancing the reentry catheter until the movable cover isdistal to the distal opening of the first catheter; and reentering thetrue lumen by opening the movable cover with the elongate medicaldevice, the movable cover being configured to facilitate reentry to thetrue lumen in an open position.
 10. The method of claim 9, furthercomprising removing the reentry catheter and leaving the elongatemedical device in place.
 11. The method of claim 9, wherein the distalside opening is marked by surrounding radiopaque material in thesidewall.
 12. The method of claim 9, wherein the movable cover comprisesone of the following mechanisms: a spring, a magnet, a stopper, or ahinge pin.
 13. The method of claim 9, wherein the movable covercomprises shape memory material.
 14. The method of claim 13, wherein themovable cover comprises radiopaque material.
 15. The method of claim 9,wherein the elongate medical device comprises radiopaque material at adistal end thereof.
 16. The method of claim 13, wherein the elongatemedical device comprises a radiopaque catheter balloon.
 17. The methodof claim 13, further comprising feeding the first catheter over theelongate medical device into the true lumen.
 18. The method of claim 13,wherein the first catheter comprises a balloon.